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Saturday, November 26, 2011

In Dec the FDA will be moving forward to reclassify herbs as drugs. All vitamin and herb supplements will be affected. If you take vitamins or herbs, you will be affected.

If they do that, what herbs are cleared will increase in price. There are thousands of herbs and supplements that are not cleared. That means that many supplements and vitamins will be taken off the shelf.

You must do your part to let the FDA know you are against this.

They do not have your safety in mind. It has to door with the pharm companies and their push to control the herbal market place.

Right now this has already happened in Europe and it can happen here. The FDA is out of control. It is in bed with the drug companies...just look at the constant drug advertising on television.

Any supplement or vitamin introduced into the marketplace after 1994 will have to go through reams of paperwork and thousands of dollars to get cleared. They will have to prove with sales receipts and marketing material that they did sell their product before 1994. How many businesses have kept records back that far.

If the company changed the way they manufactured the supplement after 1994, which most have, they must go through the whole process.

You must show safety proof for 20 years......drugs only have to go through a few weeks to be be released to the public.....so why with herbs? It is one way to stop herb and vitamin formulations from being cleared.

This will effect all supplements including Fish Oil and Vit C....all of it. They are asking for manufacturers to give the same kind of proof that drug companies have to.....studies that cost billions of dollars. This is unnecessary and will put most companies out of business. The reams of unnecessary paperwork and legal costs will kill most businesses. You must hire an expert to figure out how to comply with the pages of paperwork.

When its all said and done, you will be left with no alternative other than drugs that destroy the liver and kidneys....you will have no choice but to do that.....This is serious and they will go ahead with this in the new year.

They must be stopped. It is overreach by the FDA and will be used with bias as the case now.

With Citizens for Health supporters already having generated over 11,000 letters to Congress demanding that the FDA’s NDI (New Dietary Ingredient) Draft Guidance be withdrawn.

Being almost halfway to 10,000 signatures in a little more than 2 days means we can certainly reach our goal - but only with your participation!

As always, thanks for being involved,

Please go here to this FDA site listed below and send the FDA your view against this guidance directly! Write them...call them....all of it!

It needs to be done now!

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

Submit written comments against this NCI Guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

You can read the Nutritional Guidance paperwork here at this address below:

How many companies are going to have the money to submit to pages of regulations and hassel?

Why should vitamin and herb companies be subjected to more paperwork than a drug?

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